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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date. As noted by the authors, entities within the drug and biologic industries should continue to track FDA’s COVID-19-related actions, as additional guidance and modifications to existing guidances are likely. In fact, just days following the LawFlash, FDA updated its guidance on the Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency to further clarify procedures for informed consent and the use of remote video conference participant visits and published a new guidance on Development and Licensure of Vaccines to Prevent COVID-19. With the continuation of the pandemic and the recent surge in cases, we should expect FDA to continue to quickly push out guidances that have an immediate effect. These guidances not only provide direction on how industry can address immediate challenges and questions, but how FDA may make more enduring regulatory changes.